FITPACK WISP YOUTH

The minimalist design of the Wisp Youth nasal mask makes it both appealing and perfectly suited to all lifestyles. With an unobstructed field of vision, it provides a greater sense of freedom. The Wisp Youth nasal mask is an excellent choice for children who sleep on their side.

Includes three cushions sizes: S/M, L, XL

WARNING

Use of the mask is contraindicated for patients, their partners, caregivers, and household members who are near mask users and who have implanted metallic medical devices or metallic objects that could be affected by magnets.

These masks may continue to be used according to the updated instructions and labeling if patients or those nearby do not have implanted metallic medical devices or metallic objects in their bodies.

What is a contraindication or a warning?

A contraindication is a condition in which the device must not be used because the risk clearly outweighs any potential benefit. A warning alerts patients to a situation that, if not avoided, may result in death or serious injury. A warning may also describe serious adverse effects and potential safety risks. In summary, a contraindication tells the user when a device must not be used, while a warning explains how to avoid sources of danger when using the device.

Contraindication

Use of the mask is contraindicated for patients, their partners, caregivers, and household members who are near mask users and who have implanted devices that could be affected by magnets, including but not limited to:

• Pacemakers
• Implantable cardioverter defibrillators (ICDs)
• Neurostimulators
• Magnetic metallic implants/electrodes/valves placed in the upper limbs, torso, neck, or head
• Cerebrospinal fluid (CSF) shunts (e.g., VP shunts)
• Aneurysm clips
• Metallic embolization coils
• Devices used to disrupt intravascular flow during intracranial aneurysm treatment
• Metallic cranial plates, screws, burr hole covers, and bone substitute devices
• Metallic fragments in the eye
• Ocular implants (e.g., glaucoma implants, retinal implants)
• Certain contact lenses containing metal
• Hearing or balance restoration implants containing magnets (e.g., cochlear implants, implantable bone conduction devices, auditory brainstem implants)
• Magnetic attachments for dental prosthetics
• Gastrointestinal metallic clips
• Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary stents)
• Implantable ports and pumps (e.g., insulin pumps)
• Hypoglossal nerve neurostimulators
• Devices labeled as non-MRI compatible
• Magnetic metallic implants not labeled as MRI compatible or whose safety in magnetic fields has not been evaluated

Warning

Magnets with a magnetic field strength below 400 mT are used in the mask. Except for the devices listed under the contraindication section, ensure that the mask is kept at least 15.24 cm (approximately 6 inches) away from any other implant or medical device that could be affected by magnetic fields, to avoid potential effects from localized magnetic fields. This includes household members, caregivers, and partners who may be near patients using the masks.